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Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment

2014-08-27 03:16:32 | BioPortfolio

Summary

This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.

Description

Abacavir is an anti-HIV drug that belongs to the class of nucleosides reverse transcriptase inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and ribavirin used in this study are also FDA approved.Some individuals who have HIV infection also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level of ribavirin in the body (in the blood and in cells named peripheral blood mononuclear cells or PBMCs). Thus, taking ribavirin and abacavir together could lead to treatment failure for hepatitis C. So it is important to understand how levels of ribavirin medication are affected when the two medications are taken together.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Hepatitis C

Intervention

Ribavrin, Abacavir plus Ribavirin

Location

Johns Hopkins Drug Development Unit
Baltimore
Maryland
United States
21287

Status

Recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:32-0400

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PubMed Articles [1219 Associated PubMed Articles listed on BioPortfolio]

Cost-effectiveness of sofosbuvir plus ribavirin therapy for hepatitis C virus genotype 2 infection in South Korea.

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Medical and Biotech [MESH] Definitions

INFLAMMATION of the LIVER in humans due to infection by VIRUSES. There are several significant types of human viral hepatitis with infection caused by enteric-transmission (HEPATITIS A; HEPATITIS E) or blood transfusion (HEPATITIS B; HEPATITIS C; and HEPATITIS D).

A family of hepatotropic DNA viruses which contains double-stranded DNA genomes and causes hepatitis in humans and animals. There are two genera: AVIHEPADNAVIRUS and ORTHOHEPADNAVIRUS. Hepadnaviruses include HEPATITIS B VIRUS, duck hepatitis B virus (HEPATITIS B VIRUS, DUCK), heron hepatitis B virus, ground squirrel hepatitis virus, and woodchuck hepatitis B virus (HEPATITIS B VIRUS, WOODCHUCK).

A species in the genus HEPATOVIRUS containing one serotype and two strains: HUMAN HEPATITIS A VIRUS and Simian hepatitis A virus causing hepatitis in humans (HEPATITIS A) and primates, respectively.

INFLAMMATION of the LIVER in humans caused by HEPATITIS DELTA VIRUS, a defective RNA virus that can only infect HEPATITIS B patients. For its viral coating, hepatitis delta virus requires the HEPATITIS B SURFACE ANTIGENS produced by these patients. Hepatitis D can occur either concomitantly with (coinfection) or subsequent to (superinfection) hepatitis B infection. Similar to hepatitis B, it is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.

INFLAMMATION of the LIVER in humans caused by HEPATITIS C VIRUS, a single-stranded RNA virus. Its incubation period is 30-90 days. Hepatitis C is transmitted primarily by contaminated blood parenterally, and is often associated with transfusion and intravenous drug abuse. However, in a significant number of cases, the source of hepatitis C infection is unknown.

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